Public-private research to develop more accurate ways of measuring cancer progression

New York, NY March 27, 2017 – Columbia University Medical Center and NewYork-Presbyterian, in coordination with the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium, is launching a three-year research collaboration to develop new methods for analyzing digital images that track a patient's response to cancer therapy.

Many new cancer drugs fail in the latter stages of development, exposing patients who participate in early stage clinical trials to ineffective treatments and wasting valuable resources. In a 2012 review of 253 phase III drug clinical trials for treatment of solid tumors, 62 percent of the studies were unable to verify the expected positive benefit previously observed with the therapy in earlier stage trials. These results suggest that the tools used to assess drug benefit are inadequate for measuring efficacy in the early stages of development, and indicate the need for new methods of evaluating tumors.

The FNIH raised $2.7 million from the private sector to address these issues through a new project called "Advanced metrics and modeling with Volumetric CT for Precision Analysis of Clinical Trial results" (Vol-PACT). This project is the first to use imaging data from multiple completed, pharmaceutical industry-sponsored, phase II/III clinical trials to develop drug response metrics. "Vol-PACT's goal is to identify the optimal method of measuring and assessing tumor burden," said Lawrence Schwartz, MD, the James Picker Professor of Radiology at Columbia University Medical Center (CUMC), chair of the department of radiology at NewYork-Presbyterian/Columbia, and Co-Principal Investigator of Vol-PACT. "While there are general guidelines available for drug development, tumor response criteria are usually based on intuition. With this collaboration, we hope to define a data-driven methodology that more closely correlates tumor burden with patient outcomes." Binsheng Zhao, DSc, professor of radiology (physics) and Director of the Laboratory for Computational Image Analysis in the Department of Radiology at CUMC, will lead the effort to deliver quantitative tumor measurements from all of the clinical trials using lab-developed advanced segmentation and characterization software.

The Vol-PACT project team will analyze the imaging data to measure characteristics of cancer progression and generate potential biomarkers. Since the project has access to multiple completed datasets, the team can rapidly develop robust imaging biomarker criteria and verify their utility in different settings. The project will compare the new biomarkers to the current image analysis standards used for therapies that target specific genes and proteins, as well as those that stimulate immune response. Current methods are unable to predict the efficacy of immunotherapies in many cancer types.

"This work has the potential to improve the accuracy and efficiency of future clinical trials across multiple treatments and cancer types, to accelerate the development of cancer therapies, and improve patient care," said Dr. Schwartz.

The project team, co-led by Geoffrey Oxnard, MD, of the Dana-Farber Cancer Institute, includes experts from the National Cancer Institute and the U.S. Food and Drug Administration, as well as Co-Investigators Mithat Gonen, PhD, of Memorial Sloan Kettering Cancer Center and Michael Maitland, MD, PhD, of the Inova Center for Personalized Health and the Inova Schar Cancer Institute. To date, four companies have donated imaging and clinical trial data to support Vol-PACT and five companies have committed funding.

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For more information, see the FNIH website.

Columbia University Medical Center provides international leadership in basic, preclinical, and clinical research; medical and health sciences education; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Columbia University Medical Center is home to the largest medical research enterprise in New York City and State and one of the largest faculty medical practices in the Northeast. The campus that Columbia University Medical Center shares with its hospital partner, NewYork-Presbyterian, is now called the Columbia University Irving Medical Center. For more information, visit cumc.columbia.edu or columbiadoctors.org.

NewYork-Presbyterian is one of the nation's most comprehensive healthcare delivery networks, focused on providing innovative and compassionate care to patients in the New York metropolitan area and throughout the globe. In collaboration with two renowned medical school partners, Weill Cornell Medicine and Columbia University College of Physicians & Surgeons, NewYork-Presbyterian is consistently recognized as a leader in medical education, groundbreaking research and clinical innovation.

NewYork-Presbyterian has four major divisions: NewYork-Presbyterian Hospital is ranked #1 in the New York metropolitan area by U.S. News and World Report and repeatedly named to the magazine's Honor Roll of best hospitals in the nation; NewYork-Presbyterian Regional Hospital Network is comprised of leading hospitals in and around New York and delivers high-quality care to patients throughout the region; NewYork-Presbyterian Physician Services connects medical experts with patients in their communities; and NewYork-Presbyterian Community and Population Health features the hospital's ambulatory care network sites and operations, community

care initiatives and healthcare quality programs, including NewYork Quality Care, established by NewYork-Presbyterian, Weill Cornell and Columbia. NewYork-Presbyterian is one of the largest healthcare providers in the U.S. Each year, nearly 29,000 NewYork-Presbyterian professionals deliver exceptional care to more than 2 million patients.

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The Foundation for the National Institutes of Health creates and manages alliances with public and private institutions in support of the mission of the National Institutes of Health, the world's premier medical research agency. The Foundation, also known as the FNIH, works with its partners to accelerate biomedical research and strategies against diseases and health concerns in the United States and across the globe. The FNIH organizes and administers research projects; supports education and training of new researchers; organizes educational events and symposia; and administers a series of funds supporting a wide range of health issues. Established by Congress in 1990, the FNIH is a not-for-profit 501(c)(3) charitable organization. For additional information about the FNIH, visit fnih.org.